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ACTIVE NOT RECRUITING
NCT07385053
NA

Real-Life Evaluation of the HA Dermal Filler ESTYME® LIFT

Sponsor: Symatese

View on ClinicalTrials.gov

Summary

The objective of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of a hyaluronic acid-based dermal filler intended for the aesthetic correction of nasolabial folds. The primary question addressed by the study is: How long does the effect of the product last? Following the initial injection session, which includes an optional touch-up planned one month after the first injection, participants will attend a follow-up visit scheduled between 9 and 24 months after the initial treatment. During this visit, patients may receive a retreatment if they wish. The flexibility of the follow-up window between 9 and 24 months was defined to allow patients to return on their own initiative for retreatment, thereby indicating the end of the effect of the initial injection session. A final follow-up visit is also scheduled at 24 months. At each visit, the investigator will assess both performance and safety through a clinical examination. In addition, at each follow-up visit, participants will evaluate the aesthetic improvement compared with their pre-injection appearance.

Official title: Post-Marketing Clinical Follow Up of ESTYME® LIFT in the Correction of Nasolabial Folds

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2023-06-05

Completion Date

2026-04

Last Updated

2026-02-03

Healthy Volunteers

Yes

Interventions

DEVICE

Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).

The device will be used under real-life conditions. Following the initial injection session, an optional touch-up may be performed one month after the first injection. A retreatment session may be offered to the patient between 9 and 24 months after the initial injection.

Locations (3)

Centre Médical Saint Jean

Arras, France

Cabinet médical

Lyon, France

Palais de Flore

Lyon, France